Percutaneous methods, systems, and devices for positioning a guide wire in a bone

ABSTRACT

Minimally invasive percutaneous methods, devices, and systems for placing guide wires in bones in a desired position and orientation and for facilitating the treatment of fractures such as but not limited to intertrochanteric fractures or other applications such as osteotomies. The methods, devices, and systems may allow for rapid and reproducible placement of a guide wire in a bone. Each degree of freedom may be controlled independently.

CROSS REFERENCE

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/190,117 filed Jul. 8, 2015, the specification(s) of which is/areincorporated herein in their entirety by reference.

FIELD OF THE INVENTION

The present invention relates to methods, devices, and systems forplacement of guide wires in bones at a desired position and orientation,for example for fractures (e.g., intertrochanteric fracture of theproximal femur), more particularly to a minimally invasive percutaneoussystem for accurately, rapidly, and reproducibly placing a guide wire ina bone at a desired position and orientation.

BACKGROUND OF THE INVENTION

In orthopedic surgery one often finds it necessary to place a guide wireinto a bone in a desired position and orientation. These guide wires maybe needed to guide an osteotomy, a drill hole, the placement of acutting jig, etc. A common challenge is that there are often manydegrees of freedom (positions and angles in multiple planes) that mustbe simultaneously controlled. Commonly wire guides are placed on thebone to direct the placement of the guide wire, but this requiresexposing the bone, often necessitating a large dissection. Analternative is to achieve guide wire placement using fluoroscopy withradiographic projection of an extracorporeal guide, thus avoiding theneed for an incision to place the guide on bone. The challenge inherentin the use of fluoroscopy with an extracorporeal guide is the number ofdegrees of freedom that must be simultaneously controlled often requiresmultiple attempts at guide wire placement even by an experiencedsurgeon.

One example of an application that requires the placement of a guidewire into a bone at a precise position and orientation is the fixationof an intertrochanteric (IT) hip fracture. These fractures are commonlytreated with internal fixation employing a sliding hip screw and sideplate implant. Placement of the sliding hip screw is achieved using acannulated technique in which a guide wire is drilled from the lateralfemur across the femoral neck and into the femoral head. The positionand orientation of the guide wire is controlled with the use of an angleguide. Typically, the angle guide is placed directly onto lateral cortexof the femur. Placement of the angle guide on the femur requires a large(e.g., 15-20 cm) incision through skin, subcutaneous tissue, fascia andmuscle. A percutaneous technique (e.g., without initial incision) hasbeen previously described and has been shown to result in less bloodloss and operative time (Alobaid et al., J Orthop Trauma 18:207-212;Cheng et al., Surgical Innovation 18: 99-105; Ho et al., Int Orthop33:555-560). However, this technique relies on freehand placement of theguide wire, which can be time consuming and technically demanding sinceinstrumentation that would allow for the rapid, accurate, and repeatableplacement of the guide wire does not exist.

In order to make the process of percutaneously placing a guide wire intobone at a desired position and orientation simple, rapid, accurate andrepeatable, the present invention allows for each degree of freedom tobe independently controlled and then fixed, e.g., the methods, devices,and systems of the present invention may help fix the position and/orangle of the guide wire with respect to the bone in a rapid, accurate,and repeatable manner. As a non-limiting example in the case offacilitating the treatment of an IT fracture, the methods, devices, andsystems of the present invention may help fix the position and angle inthe frontal and transverse planes for the guide wire used for slidinghip screw implantation. The present invention is not limited toapplications related to fractures, e.g., IT fractures. The presentinvention may be used for any appropriate procedure or application inwhich a guide wire is to be placed at a prescribed position andorientation in a bone. Non-limiting examples of applications include theplacement of guide pins for cannulated screws osteotomies, cutting jigs,fracture reduction and fixation, and the like. Furthermore, the devicesand systems of the present invention are not limited to the particularconfigurations described herein. The parameters (e.g., sizes, angles,etc.), configurations, and uses of the systems and devices disclosedherein may be modified to accommodate the anatomic location andposition/orientation requirements for which it is used.

Without wishing to limit the present invention to any theory ormechanism, it is believed that the systems, methods, and devices of thepresent invention create a minimally invasive means of properly placinga guide wire in a bone. The systems, methods, and devices of the presentinvention may help improve accuracy and repeatability when placing theguide wire in a bone. The systems, methods, and devices of the presentinvention may also help avoid putting multiple holes in the bone, whichmay help lessen the chance of a postoperative fracture. The systems,methods, and devices of the present invention may also help reduceincision size, surgery time, and possibly blood loss.

Any feature or combination of features described herein are includedwithin the scope of the present invention provided that the featuresincluded in any such combination are not mutually inconsistent as willbe apparent from the context, this specification, and the knowledge ofone of ordinary skill in the art. Additional advantages and aspects ofthe present invention are apparent in the following detailed descriptionand claims.

SUMMARY OF THE INVENTION

The present invention features percutaneous devices, systems, andmethods for placing a guide wire into a bone at a desired position andorientation, wherein each degree of freedom may be controlled and/orfixed independently. There are six degrees of freedom that may berequired to fully specify the position and orientation of a body in 3Dspace. There are a number of ways to represent these six degrees offreedom. One way is to specify three positions and three angles. Inorthopedic surgery, these degrees of freedom are often specifiedrelative to the anatomic axes of the limb. One example of such set isthree angles (flexion/extension, varus/valgus, and internal/externalrotation) and three positions (superior/inferior, anterior/posterior,and medial/lateral).

The present invention features an external guide system for placing aguide wire into a bone at a particular position and orientation. In someembodiments, the system comprises an alignment plate; at least a firstwing extending downwardly from a first side of the alignment plate,wherein the first wing is adapted to directly or indirectly position andhold a placement pin; a slide bar slidably engaged in a channel disposedin the alignment plate, wherein the slide bar extends downwardly fromthe alignment plate and the slide bar can slide in at least a firstdirection toward a first end of the alignment plate and a seconddirection toward a second end of the alignment plate; and a guide wiregrip adapted to position and hold a guide wire. In some embodiments, theguide wire grip is pivotally attached to a guide wire grip base whereinthe guide wire grip can pivot within the guide wire grip base in a firstdirection toward the alignment plate and a second direction opposite thefirst direction. In some embodiments, the guide wire grip base isslidably attached to the slide bar such that it can slide in a firstdirection toward the alignment plate and a second direction opposite thefirst direction. The system is adapted to allow independent positioningof flexion-extension angle, varus-valgus angulation, internal-externalrotation angle, superior-inferior position, anterior-posterior position,and medial-lateral position of the guide wire.

In some embodiments, the system further comprises a second wingextending downwardly from a second side of the alignment plate oppositethe first side, wherein the second wing is adapted to directly orindirectly accept a placement pin. In some embodiments, the first wingand the second wing are separated by a distance.

In some embodiments, the system comprises a positioning pin grip adaptedto position and hold a positioning pin directly or indirectly slidablyattached to the first wing, wherein the positioning pin grip can be slidin a first direction toward the alignment plate and a second directionopposite the first direction. In some embodiments, the positioning pingrip is attached to a positioning pin grip base, which is slidablyattached to the first wing, wherein the positioning pin grip base slidesin a first direction toward the alignment plate and a second directionopposite the first direction. In some embodiments, the positioning pingrip comprises a positioning pin grip slot adapted to accept apositioning pin.

In some embodiments, the first wing comprises a plurality of holesdisposed therethrough that allow passage of a placement pin, wherein theholes are at a first hole angle with respect to the length of the firstwing and at a second hole angle with respect to the width of the firstwing. In some embodiments, the second wing comprises a plurality ofholes disposed therethrough that allow passage of a placement pin,wherein the holes are at a first hole angle with respect to the lengthof the second wing and at a second hole angle with respect to the widthof the second wing. In some embodiments, the first hole angle is from 20to 90 degrees and the second hole angle is from 20 to 90 degrees. Insome embodiments, the slide bar slidably engages the channel via aconnector.

In some embodiments, the slide bar comprises a guide wire grip shaft,wherein the guide wire grip base is slidably attached to the guide wiregrip shaft and can slide in the first direction and second directionalong the slide bar via the guide wire grip shaft. In some embodiments,the guide wire grip base engages a slot is disposed in the slide bar,wherein the slot extends along at least a part of a length of the slidebar. In some embodiments, the guide wire grip comprises a guide wiregrip slot adapted to accept a guide wire, wherein a guide wire can slidewithin the guide wire grip slot in a first direction and seconddirection opposite the first direction. In some embodiments, the guidewire grip comprises one more guide wire grip holes adapted to accept aguide wire.

In some embodiments, the system further comprises an alignment bardisposed on or in the alignment plate; the alignment bar is a guide forplacing the alignment plate on a subject.

In some embodiments, the system is for placing a guide wire into a bonefor facilitating treatment of a fracture or an osteotomy.

The present invention also features methods for positioning a guide wireinto a bone at a particular position and orientation. In someembodiments, the method comprises placing an external guide system ofthe present invention atop a treatment area of a subject, positioning atleast one placement pin directly or indirectly in the first wing andfurther into the bone to secure the external angle guide system inplace; positioning the slide bar to an appropriate position within thechannel; and inserting a guide wire through the guide wire grip andfurther into a bone.

In some embodiments, the method further comprises pivoting the guidewire grip within the guide wire grip base to help position the guidewire. In some embodiments, the method further comprises sliding theguide wire grip base on the slide bar to help position the guide wire.In some embodiments, the method further comprises securing the slide barin the channel via a locking component. In some embodiments, the methodis for facilitating the treatment of a fracture or an osteotomy.

The present invention also features an external guide system comprising:an alignment plate; a first wing and a second wing both extendingdownwardly from the alignment plate on opposite sides; a positioning pingrip slidably attached to each wing, the positioning pin grips can beslid in a first direction toward the alignment plate and a seconddirection opposite the first direction, wherein each positioning pingrip comprises a positioning pin grip slot adapted to accept a placementpin; a slide bar slidably engaged in a channel disposed in the alignmentplate, the slide bar extends downwardly from the alignment plate, theslide bar can slide in at least a first direction toward a first end ofthe alignment plate and a second direction toward a second end of thealignment plate; a guide wire grip with a guide wire grip slot disposedtherein adapted to position and hold a guide wire, the guide wire gripis pivotally attached to a guide wire grip base wherein the guide wiregrip can pivot within the guide wire grip base in a first directiontoward the alignment plate and a second direction opposite the firstdirection, wherein the guide wire grip base is slidably attached to aguide wire grip shaft disposed on the slide bar such that it can slidein a first direction toward the alignment plate and a second directionopposite the first direction. The system is adapted to allow independentpositioning of flexion-extension angle, varus-valgus angulation,internal-external rotation angle, superior-inferior position,anterior-posterior position, and medial-lateral position of the guidewire.

In some embodiments, a percutaneous device for placing a guide wire in abone comprises an external guide system. In some embodiments, the systemcomprises an alignment plate, wherein an alignment bar (e.g., a linearor nearly linear alignment bar) is disposed in or on a top surface ofthe alignment plate; at least a first wing that extends downwardly froma first side of the alignment plate, wherein the first wing is adaptedto allow passage of a placement pin therethrough at a first hole anglewith a length of the first wing and at a second hole angle with respectto a width of the first wing; and a slide bar slidably engaged in achannel disposed in the top surface of the alignment plate, wherein theslide bar extends downwardly from the alignment plate and the slide barcan slide in at least a first direction toward a first end of thealignment plate and a second direction toward a second end of thealignment plate. In some embodiments, a slot is disposed in the slidebar extending along at least a part of a length of the slide bar,wherein the slot is adapted to accept a guide wire. The slot may be atan angle with respect to a width of the slide bar.

In some embodiments, the alignment plate is a femoral alignment plate.In some embodiments, the guide wire is a central guide wire.

In some embodiments, the alignment bar is perpendicular to the length ofthe alignment plate. In some embodiments, the alignment bar extends fromat or near a first end to at or near a second end of the alignmentplate. In some embodiments, the alignment bar comprises a groove, anindentation, a protrusion, a marking, or a combination thereof. In someembodiments, the system further comprises a second wing that extendsdownwardly from the first side of the alignment plate, wherein thesecond wing is adapted to allow passage of a placement pin therethroughat a first hole angle with respect to a length of the second wing and ata second hole angle with respect to a width of the second wing. Thefirst wing and the second wing may be separated by a distance.

In some embodiments, the first wing comprises a plurality of holesdisposed therethrough that allow passage of a placement pin, wherein theholes are at a first hole angle with respect to the length of the firstwing and at a second hole angle with respect to the width of the firstwing. In some embodiments, the second wing comprises a plurality ofholes disposed therethrough that allow passage of a placement pin,wherein the holes are at a first hole angle with respect to the lengthof the second wing and at a second hole angle with respect to the widthof the second wing. In some embodiments, the channel extends from at ornear the first end to at or near the second end of the alignment plate.In some embodiments, the slide bar slidably engages the channel via aconnector. In some embodiments, the system further comprises a lockingcomponent adapted to secure the slide bar in a position with respect tothe channel. In some embodiments, the slide bar comprises more than oneslot. In some embodiments, the slide bar is removable.

The present invention also features methods of facilitating thetreatment of a fracture (e.g., an IT fracture). In some embodiments, themethod comprises placing an external angle guide system according to thepresent invention atop a leg of a patient; aligning the alignment barwith a femur of the patient; driving at least one placement pin throughthe first wing and further into the femur to secure the external angleguide system in place; positioning the slide bar to an appropriateposition; inserting a guide wire through the slot and further into thefemoral head of the femur; and implanting a dynamic hip screw into thefemur. In some embodiments, the method further comprises securing theslide bar in the channel via a locking component.

The present invention also features a method of placing a guide wire(e.g., a central guide wire) into a bone at a desired position andorientation, wherein each degree of freedom may be controlled and/orfixed independently. In some embodiments, the method comprises placingan external angle guide system according to the present invention atop atreatment area of a patient. In some embodiments, the treatment area ofthe patient is the leg, e.g., thigh area. The present invention is notlimited to applications related to leg and hip bones. As such, thetreatment area of the patient may be any appropriate area wherein aguide wire is to be inserted into a bone. The method may furthercomprise aligning the alignment bar with a bone (e.g., femur) of thepatient and driving at least one placement pin through the first wingand further into the bone (e.g., femur) to secure the external angleguide system in place. The method may further comprise positioning theslide bar at an appropriate position. In some embodiments, the methodfurther comprises securing the slide bar in the channel via a lockingcomponent. The method further comprises inserting a guide wire throughthe slot and further into the bone.

As an example (e.g., in a case of facilitating the treatment of an ITfracture), in some embodiments, the method (percutaneous method) ofplacing a guide wire into a bone at a desired position and orientationcomprises one or more of the steps: placing a guide system (e.g., anexternal guide system of the present invention) on the patient's thigh,aligning a guide system (e.g., an external guide system) in the frontalplane (varus/valgus), fixing the guide system to the femur, selectingthe superior/inferior position and fixing it, selecting the transverseplane angulation (internal/external rotation) fixing it, and selectingthe sagittal plane position (anterior/posterior). The present inventionis not limited to applications related to facilitating the treatment ofan IT fracture, and the steps of the methods of the present inventionmay be modified as appropriate for the application.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A (prior art) shows a DHS angle guide with a guide wire held upover the thigh aligned with a pin that is in the femur.

FIG. 1B (prior art) shows a fluoroscopic image of the freehand placementof the guide wire shown in 1A.

FIG. 2A shows an in-use view of an embodiment of an external angle guidesystem of the present invention.

FIG. 2B shows a top view and in-use view of the external angle guidesystem of FIG. 2A.

FIG. 2C shows a side view and in-use view of the external angle guidesystem of FIG. 2A.

FIG. 3 shows a perspective view of an alternative embodiment of anexternal angle guide system of the present invention.

FIG. 4A and FIG. 4B show the placement of an external angle guide (suchas that of FIG. 3) on an artificial femur. Athletic tape was used tomock the skin and muscle atop the artificial femur. Note: A slide bar isnot shown in FIG. 4A and FIG. 4B.

FIG. 5A is a side view of a wing, illustrating a hole at an angle withrespect to the outer surface of the wing (as shown along the length ofthe wing from the top end to the bottom end).

FIG. 5B is a top view of a wing, illustrating a hole at an angle withrespect to the outer surface of the wing (as shown along the width ofthe wing from the first side to the second side).

FIG. 5C is a top view of the slide bar, illustrating a slot at an anglewith respect to the outer surface of the slide bar (as shown along thewidth of the slide bar from the first side to the second side).

FIG. 6A shows a perspective view of an external angle guide system ofthe present invention.

FIG. 6B shows a perspective view of a guide arm of the external angleguide system of FIG. 6A. The alignment plate is not shown in FIG. 6B.

FIG. 6C shows a perspective view of a guide wire grip base of theexternal angle guide system of FIG. 6A (the guide arm and the alignmentplate are not shown in FIG. 6C).

FIG. 6D shows a side view of the guide wire grip base of FIG. 6C.

FIG. 6E shows an in-use view of the external angle guide system of FIG.6A.

FIG. 7 shows a perspective view of an alternative embodiment of anexternal angle guide system of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Following is a list of elements corresponding to a particular elementreferred to herein:

-   -   50 femur    -   100 external angle guide system    -   102 guide wire (e.g., central guide wire)    -   103 DHS angle guide (prior art)    -   105 positioning pin    -   110 alignment plate (e.g., femoral alignment plate)    -   111 first end of alignment plate    -   112 second end of alignment plate    -   113 first side of alignment plate    -   114 second side of alignment plate    -   115 top surface of alignment plate    -   118 alignment bar    -   120 wing    -   120 a first wing    -   120 b second wing    -   120 c first wing channel    -   120 d second wing channel    -   121 bottom end of wing    -   122 top end of wing    -   123 inner surface of wing    -   124 outer surface of wing    -   125 first side of wing    -   126 second side of wing    -   128 holes (e.g., channels through wings)    -   129 a first hole angle    -   129 b second hole angle    -   130 channel    -   140 slide bar    -   141 first side of slide bar    -   142 second side of slide bar    -   144 outer surface of slide bar    -   144 locking component    -   145 connector hole    -   148 connector    -   150 slot    -   159 slot angle    -   160 guide wire grip    -   162 guide wire grip slot    -   164 guide wire grip shaft    -   166 guide wire grip base    -   168 guide wire grip hole    -   169 guide wire grip base channel    -   170 positioning pin grip    -   172 positioning pin grip slot    -   176 positioning pin grip base    -   182 tightening screw hole    -   184 gripping component    -   188 screw fixation track

Referring now to FIG. 1A and FIG. 1B, as previously discussed, currentmethods of treating stable intertrochanteric (IT) hip fractures includeusing a dynamic hip screw (DHS) comprising a dynamic compression plate(DCP) with a barrel and an intramedullary screw (DHS screw).Implantation of the DHS requires the placement of a DHS angle guide(103) directly on the femur so that the guide wire (102) (or guide pin)can be inserted. The guide wire (or guide pin) must be placed in thecenter of the femoral head at the correct angle. FIG. 1A shows a DHSangle guide (103) with a guide wire held up over the thigh aligned witha pin that is in the femur, and FIG. 1B shows a fluoroscopic image ofthe freehand placement of the guide wire (102) shown in 1A.

Referring now to FIG. 2-7, the present invention features percutaneousmethods, devices, and systems for positioning a guide wire (102) in abone at a desired position and orientation, wherein each degree offreedom may be controlled independently. For example, the presentinvention features methods of facilitating the treatment of fractures(fractures may include but are not limited to IT fractures), wherein themethods utilize guide systems (100) described herein. As an examplerelated to IT fractures, an external angle guide system (100) of thepresent invention may be positioned on top of the patient's leg. Theexternal angle guide system (100) of the present invention allows foraccurate and rapid placement of a guide wire (102) without the need of alarge (e.g., 15 to 20 cm) surgical incision. In some embodiments, theguide wire (102) is a central guide wire.

The guide systems (100) of the present invention are not limited to thecomponents, configurations, and uses described herein.

As shown in FIG. 2A, FIG. 2B, and FIG. 2C, the external guide system(100) of the present invention comprises an alignment plate (110) (e.g.,a femoral alignment plate). For clarity with respect to the drawings,the alignment plate (110) comprises a first end (111), a second end(112) opposite the first end (111), a first side (113) (e.g., a frontend if viewed as in FIG. 2A), a second side (114) opposite the firstside (113), a top surface (115), and a bottom surface; however, thesedistinctions are not meant to limit the system (100) in any way. In someembodiments, for example for applications related to facilitating thetreatment of an IT fracture, the alignment plate may be for placing atopthe patient's leg, e.g., atop the quadriceps area. Note the presentinvention is not limited to the treatment of IT fractures. Also, whilethe examples shown in FIG. 2A, FIG. 2B, and FIG. 2C show the system(100) placed atop a patient's leg for guide pin insertion into the femur(50), the present invention is not limited to placement over or near thefemur (50).

In some embodiments, the system (100) further comprises one or morewings that extend from the first side (113) (e.g., downwardly) from thefirst side (113) of the alignment plate (110), e.g., the wings beingpositioned on opposite sides of the alignment plate (110). In someembodiments, the wings (120) resemble shafts or cylinders, however thewings are not limited to a shaft or cylindrical configuration. Thesystem (100) may comprise a first wing (120 a) and a second wing (120 b)that extend downwardly (or downwardly and outwardly) from the first side(113) of the alignment plate (110). The first wing (120 a) may bepositioned at or near the first end (111) of the alignment plate (110),and the second wing (120 b) may be positioned at or near the second end(112) of the alignment plate (110). The wings (120) may be spaced adistance apart (e.g., as shown in FIG. 2A). In some embodiments, thewings (120) extend through wing channels in the alignment plate (110),e.g., the first wing (120 a) extends through a first wing channel (120c) in the alignment plate (110), the second wing (120 b) extends througha second wing channel (120 d) in the alignment plate (110). In someembodiments, the wings (120) are perpendicular to the alignment plate(110). In some embodiments the wings (120) are at an angle with respectto the alignment plate (110), the angle being less than 90 degrees. Insome embodiments, the wings (120) are at an angle with respect to thealignment plate (110), the angle being more than 90 degrees.

Slidably disposed on each wing (120) is a positioning pin grip (170)adapted to secure a positioning pin (105) in a particular location andorientation. In some embodiments, the positioning pin grip (170) isconnected (slidably) to the wing (120) via a positioning pin grip base(176). The positioning pin grip base (176) may slide in a firstdirection and a second direction (e.g., upwardly, downwardly) along thewing (120) and may be secured in a particular position via a securingcomponent. In some embodiments, the positioning pin grip base (176)functions as a clamp around the wing (120) (e.g., tightening thepositioning pin grip base (176) may secure the positioning pin grip base(176) in place with respect to the wing (120)); however the positioningpin grip base (176) is not limited to this configuration. Thepositioning pin grip (170) comprises a positioning pin grip slot (172)adapted to accept a positioning pin (105). The positioning pin (105) maybe secured within the positioning pin grip slot (172) via a securingcomponent. In some embodiments, the positioning pin grip (170) (withslot (172)) functions as a clamp around the positioning pin (105) (e.g.,tightening the positioning pin grip (170) may secure the positioning pin(105) in place with respect to the positioning pin grip slot (172));however the positioning pin grip (170) is not limited to thisconfiguration.

In some embodiments, the system (100) further comprises a slide bar(140) with a connecter (148) that is adapted to engage with and slide ina channel (130) disposed in the top surface (115) of the alignment plate(110). (In some embodiments, a channel (130) may extend from at or nearthe first end (111) to at or near the second end (112) of the alignmentplate (110). In some embodiments, the channel (130) extends through onlya portion of the top surface (115) of the alignment plate (110).) Asshown in FIG. 2A, the slide bar (140) extends downwardly from thealignment plate (110), e.g., similar to the extension downwardly of thewings (120), though the positioning of the slide bar (140) is notlimited to the positioning or direction of the wings (120)). In someembodiments, the slide bar (140) can slide in at least a first directiontoward the first end (111) of the alignment plate (110) and/or the firstwing (120 a) and a second direction toward the second end (112) of thealignment plate (110) and/or the second wing (120 b). In someembodiments, the wings (120) limit the distance the sliding bar (140)can slide. In some embodiments, the slide bar (140) comprises aconnector (148), which slidably engages the channel (130). In someembodiments, the slide bar (140) further comprises a locking componentfor securing the slide bar (140) in place within the channel (130). Insome embodiments, the locking component is integrated into the connector(148), e.g., the connector (148) functions as a locking component totemporarily secure the slide bar (140) in a particular place.

As shown in FIG. 2A, FIG. 2B, and FIG. 2C, in some embodiments, a guidewire grip (160) is disposed on the slide bar (140). The guide wire grip(160) functions to secure a guide wire (102) in a particular positionand orientation. In some embodiments, the guide wire grip (160)comprises a guide wire grip slot (162) adapted to accept a guide wire(102). In some embodiments, a guide wire (102) can slide in a firstdirection and second direction (e.g., side to side as viewed from thedirection shown in FIG. 2A) within the guide wire slot (162). The guidewire grip (160) may be pivotally or rotatably attached to the slide bar(140) via a guide wire grip base (166). In some embodiments, the guidewire grip (160) can pivot in a first direction and second direction(e.g., upwardly, downwardly as viewed from the direction shown in FIG.2A) with respect to the guide wire grip base (166). In some embodiments,the guide wire grip base (166) is slidably attached to the slide bar(140). For example, in some embodiments, a guide wire grip shaft (164)is disposed on the slide bar (140), and the guide wire grip base (166)is slidably attached to the guide wire grip shaft (164). In someembodiments, the guide wire grip base (166) can slide upwardly anddownwardly along the guide wire grip shaft (164). The movement of theslide bar (140) along the channel (130), the movement of the guide wiregrip base (166) along the guide wire grip shaft (164) of the slide bar(140), the pivoting of the guide wire grip (160) in the guide wire gripbase (166), and the movement of the guide wire (102) in the guide wiregrip slot (162) allow for many different positions, angles, andorientations of the guide wire with respect to the patient and the areaof interest.

In some embodiments, a securing component or the slide bar (140) itselfcan temporarily secure the slide bar (140) in a position (e.g., desiredposition) with respect to the channel (130). In some embodiments, asecuring component or the guide wire grip base (166) itself cantemporarily secure the guide wire grip base (166) in a position (e.g., adesired position) with respect to the guide wire grip shaft (164) of theslide bar (140). In some embodiments, a securing component of the guidewire grip (160) itself can temporarily secure the guide wire grip (160)in a position (e.g., a desired position) with respect to the guide wiregrip base (166). In some embodiments, a securing component or the guidewire grip slot (162) itself can temporarily secure the guide wire (102)in a position (e.g., a desired position) with respect to the guide wiregrip slot (162).

As shown in FIG. 3, FIG. 4A, and FIG. 4B, an alternative embodiment ofthe external guide system (100) of the present invention comprises analignment plate (110) (e.g., a femoral alignment plate). For claritywith respect to the drawings, the alignment plate (110) comprises afirst end (111), a second end (112) opposite the first end (111), afirst side (113), a second side (114) opposite the first side (113), atop surface (115), and a bottom surface; however, these distinctions arenot meant to limit the system (100) in any way. In some embodiments, thesystem (100) further comprises one or more wings that extend from thefirst side (113), e.g., outwardly and downwardly from the first side(113), of the alignment plate (110). For example, the system (100) maycomprise a first wing (120 a) and a second wing (120 b) that extendoutwardly and downwardly from the first side (113) of the alignmentplate (110). In some embodiments, the intersection of the wings (120),e.g., the top end (121) of the wings (120), and the side (113) of thealignment plate (110) is curved, e.g., as shown in FIG. 3. However, thesystem (100) is not limited to this configuration, e.g., the wings (120)(e.g., the top ends (121) of the wings (120)) and alignment plate (110)(e.g., the first side (113) of the alignment plate (110)) may join at aright angle, for example. In some embodiments, the first wing (120 a) ispositioned at or near the first end (111) of the alignment plate (110).In some embodiments, the second wing (120 b) is positioned at or nearthe second end (112) of the alignment plate (110). In some embodiments(e.g., in some cases related to facilitating the treatment of ITfractures), when the system (100) is in use, the wings (120) extenddownwardly from the quadriceps area. In some embodiments, the wings(120) are separated by a distance. For clarity with respect to thedrawings, the wings (120) have a top end (121), a bottom end (122)opposite the top end (121), a first side (125), a second side (126)opposite the first side (125), an outer surface (123), and an innersurface (124); however, these distinctions are not meant to limit thesystem (100) in any way.

Disposed in the wings (120) is a plurality of holes (128) (or channelsthrough the wings). Without wishing to limit the present invention toany theory or mechanism, it is believed that the particularconfiguration of the holes may not necessarily be as important as theability to rigidly fix to the bone (e.g., femur).

In some embodiments, the holes (128) extend from the outer surface (123)of the wing (120) to the inner surface (125) of the wing (120) (theinner surface (125) referring to the surface that contacts the patient),e.g., forming a channel. The holes (128) may be placed at an angle withrespect to the outer surface (124) and/or inner surface (124) of thewing (120). The holes (128) may be configured in rows and/or columns.The holes (128) may be configured in pairs that are aligned in rows(e.g., a first hole is disposed in the first wing and a second hole isdisposed in the second wing, and the two holes are aligned with oneanother with respect to the position along the length/height of thewing). The holes (128) are adapted to accept placement pins (105), e.g.,placement pins (105) for inserting into the bone, e.g., the femur (e.g.,see FIG. 4A, FIG. 4B). In some embodiments, the holes of the pairs maybe at different angles. However, the present invention is not limited tothis configuration and the holes of the pair may be constructed atsimilar angles. The placement pins (105) are adapted to help secure theexternal angle guide system (100) of the present invention in place.Without wishing to limit the present invention to any theory ormechanism, holes having different angles may be useful for helping tosecure the system (100) in place, e.g., the placement pins being atdifferent angles may be more secure. In some embodiments, a user canchoose two holes that are at two different angles, but the holes are notnecessarily considered to be a pair (e.g., on the exact same row). Thepairs of holes (e.g., channels through the wings) may be constructedhaving different angles. The wings are not limited to a single column ofholes, e.g., the wings may have one, two, three, or more than threecolumns of holes.

In some embodiments, the wings (120) do not necessarily have holes butare constructed from one or more materials that allow for penetrationwith a positioning pin (105) and also allow for holding the positioningpin (105) in place once inserted. For example, the wings (120) may beconstructed from one or more materials that are soft enough to bepenetrated by the positioning pin (105) but firm enough to hold thepositioning pin (105) in place once inserted therein. Otherconfigurations may be contemplated; for example, in some embodiments,rods are used in lieu of wings (and optionally external fixator pins areused, optionally pinning to bar clamps, etc.).

In some embodiments, the holes (128) in the wings (120) are at an anglewith respect to the wings (120), e.g., the outer surfaces (124) of thewings (120). As shown in FIG. 5A, the holes (128) are at a first holeangle (129 a) with respect to the length of the wing (120), e.g., theouter surface (124) along its length as viewed from the top end (121) tothe bottom end (122) of the wing. Note that the first hole angle is thesmaller of the two angles formed, e.g., the first hole angle may be Xdegrees, and its opposite angle is 180-X, wherein X is 90 or less. Asshown in FIG. 5B, the holes (128) are at a second hole angle (129 b)with respect to the width of the wing (120), e.g., the outer surface(124) along its width as viewed from the first side (125) to the secondside (122) of the wing (120). Note that the second hole angle is thesmaller of the two angles formed, e.g., the second hole angle may be Xdegrees, and its opposite angle is 180-X, wherein X is 90 or less.

In some embodiments, the first hole angle (129 a) is from 10 to 90degrees. In some embodiments, the first hole angle (129 a) is from 20 to90 degrees. In some embodiments, the first hole angle (129 a) is from 30to 90 degrees. In some embodiments, the first hole angle (129 a) is from40 to 90 degrees. In some embodiments, the first hole angle (129 a) isfrom 50 to 90 degrees. In some embodiments, the first hole angle (129 a)is from 60 to 90 degrees. In some embodiments, the first hole angle (129a) is from 70 to 90 degrees. In some embodiments, the first hole angle(129 a) is from 80 to 90 degrees.

In some embodiments, the second hole angle (129 b) is from 10 to 90degrees. In some embodiments, the second hole angle (129 b) is from 20to 90 degrees. In some embodiments, the second hole angle (129 b) isfrom 30 to 90 degrees. In some embodiments, the second hole angle (129b) is from 40 to 90 degrees. In some embodiments, the second hole angle(129 b) is from 50 to 90 degrees. In some embodiments, the second holeangle (129 b) is from 60 to 90 degrees. In some embodiments, the secondhole angle (129 b) is from 70 to 90 degrees. In some embodiments, thesecond hole angle (129 b) is from 80 to 90 degrees.

The wings (120) may each comprise one or more or a plurality of holes,and the holes may be at similar or different angles with respect to theouter surface (124) of the wing (120).

In some embodiments, an alignment bar (118) (e.g., a linear marking,groove, indentation, protrusion, etc.) is disposed in the top surface(115) of the alignment plate (110). In some embodiments, the alignmentbar (118) extends from at or near the first end (111) to at or near thesecond end (112). In some embodiments, the alignment bar (118) extendsthrough only a portion of the top surface (115) of the alignment plate(110). In some embodiments, the alignment bar (118) is intended to serveas a guide for placement of the system (100), wherein the alignment bar(118) is for aligning with the femur of the patient. In someembodiments, the alignment bar (118) is a groove or indentation. In someembodiments, the alignment bar (118) is a protrusion. In someembodiments, the alignment bar is a marking on the alignment plate(110).

A channel (130) may be disposed in the top surface (115) of thealignment plate (110). The channel (130) may extend from at or near thefirst end (111) to at or near the second end (112) of the alignmentplate (110). In some embodiments, the channel (130) extends through onlya portion of the top surface (115) of the alignment plate (110).

In some embodiments, the system (100) further comprises a slide bar(140) with a connecter (148) that is adapted to engage with and slide inthe channel (130). The slide bar (140) extends downwardly, e.g., similarto the extension direction of the wings (120) (though not limited to theextension direction of the wings). The slide bar (140) can slide in atleast a first direction toward the first end (111) of the alignmentplate (110) and/or the first wing (120 a) and a second direction towardthe second end (112) of the alignment plate (110) and/or the second wing(120 b). In some embodiments, the wings (120) limit the distance thesliding bar (140) can slide. In some embodiments, the slide bar (140)comprises a locking component (144) for securing the slide bar (140) inplace within the channel (130). In some embodiments, the lockingcomponent (144) is integrated into the connector (148), e.g., theconnector (148) functions as a locking component.

A slot (150) (or two slots, or more than two slots) may be disposed inthe slide bar (140) extending from the outer surface and through theinner surface (the inner surface being the surface facing the patient)and may run along part or all of the length of the slide bar (140),e.g., from near the top of the slide bar to near the bottom of the slidebar (140). The slot (150) is adapted to accept the guide wire (102). Theslot (150) may be configured to help insert the guide wire (102)appropriately, e.g., to position and angle the guide wire (120)appropriately.

In some embodiments, the slot (150) is at a slot angle (159) withrespect to the width of the slide bar (140), e.g., the outer surface(144) of the slide bar (140) along its width, e.g., as viewed from thefirst side (141) to the second side (142) of the slide bar (140) (seeFIG. 5C). Note that the slot angle (159) is the smaller of the twoangles formed, e.g., the slot angle (159) may be X degrees, and itsopposite angle is 180-X, wherein X is 90 or less. This allows the guidepin (102) to be placed at a desired angle.

In some embodiments, the slot angle (159) is about 45 degrees. In someembodiments, the slot angle (159) is from 20 to 90 degrees. In someembodiments, the slot angle (159) is from 30 to 90 degrees. In someembodiments, the slot angle (159) is from 40 to 90 degrees. In someembodiments, the slot angle (159) is from 50 to 90 degrees. In someembodiments, the slot angle (159) is from 60 to 90 degrees. In someembodiments, the slot angle (159) is from 70 to 90 degrees. In someembodiments, the slot angle (159) is from 80 to 90 degrees.

In some embodiments, the slide bar (140) comprises more than one slot(150), and the slots are each at a different slot angle (159) withrespect to the outer surface (144) of the slide bar (140). In someembodiments, the slide bar (140) comprises more than one slot (150), andthe slots are each at the same slot angle (159) with respect to theouter surface (144) of the slide bar (140). In some embodiments, theslide bar (140) is removable and can be replaced with a different slidebar (140) having a slot (or more than one slot) having a different slotangle (159). This may allow the physician or health care worker toselect a particular angle as needed.

In some embodiments, the system (100) further comprises a first guidewire locking component (not shown) for securing the guide wire (102) ata particular position within the slot (150) (with respect to the lengthof the slide bar (140), e.g., the distance between the guide wire (102)and the top end of the slot (150)). In some embodiments, the system(100) further comprises a second guide wire locking component (notshown) for securing the guide wire (102) at a particular angle withinthe slot (150) (with respect to the slide plate (140)).

FIG. 6A, FIG. 6B, FIG. 6C, FIG. 6D, and FIG. 6E show an alternativeembodiment of a system (100) of the present invention. In someembodiments, the external guide system (100) of the present inventioncomprises an alignment plate (110) and one or more wings (120) thatextend from the first side (113) (e.g., downwardly) from the first side(113) of the alignment plate (110), e.g., the wings (120) beingpositioned on opposite sides of the alignment plate (110). The system(100) may comprise a first wing (120 a) and a second wing (120 b) thatextend downwardly (or downwardly and outwardly) from the first side(113) of the alignment plate (110). In some embodiments, at least aportion of the alignment plate (110) and/or wings (120) is coated with agripping component (184). For example, as shown in FIG. 6A, a portion ofthe alignment plate (110) near the first side (113) is coated with agripping component (184).

In some embodiments, the system (100) further comprises a slide bar(140) adapted to engage with and slide in a channel (130) disposed inthe top surface (115) of the alignment plate (110). (In someembodiments, a channel (130) may extend from at or near the first end(111) to at or near the second end (112) of the alignment plate (110).In some embodiments, the channel (130) extends through only a portion ofthe top surface (115) of the alignment plate (110).) In someembodiments, the slide bar (140) comprises a connector (148), whichslidably engages the channel (130). As shown in FIG. 6B, the connector(148) may be disposed in a connector hole (145) in the slide bar (140).In some embodiments, the slide bar (140) can slide in at least a firstdirection toward the first end (111) of the alignment plate (110) and/orthe first wing (120 a) and a second direction toward the second end(112) of the alignment plate (110) and/or the second wing (120 b). Insome embodiments, the wings (120) limit the distance the sliding bar(140) can slide. In some embodiments, the slide bar (140) furthercomprises a locking component for securing the slide bar (140) in placewithin the channel (130). In some embodiments, the locking component isintegrated into the connector (148) or is the connector (148) itself,e.g., the connector (148) functions as a locking component totemporarily secure the slide bar (140) in a particular place.

In some embodiments, a plurality of holes (128) (or channels) isdisposed in the wings (120).

The holes (128) may be placed at an angle with respect to the outersurface (124) and/or inner surface (124) of the wing (120). The holes(128) may be configured in rows and/or columns. The holes (128) may beconfigured in pairs that are aligned in rows (e.g., a first hole isdisposed in the first wing and a second hole is disposed in the secondwing, and the two holes are aligned with one another with respect to theposition along the length/height of the wing). The holes (128) areadapted to accept placement pins (105), e.g., placement pins (105) forinserting into the bone. In some embodiments, the holes of the pairs maybe at different angles. However, the present invention is not limited tothis configuration and the holes of the pair may be constructed atsimilar angles. In some embodiments, a user can choose two holes thatare at two different angles, but the holes are not necessarilyconsidered to be a pair (e.g., on the exact same row). The pairs ofholes (e.g., channels through the wings) may be constructed havingdifferent angles. The wings are not limited to a single column of holes,e.g., the wings may have one, two, three, or more than three columns ofholes. The wings (120) may each comprise one or more or a plurality ofholes, and the holes may be at similar or different angles with respectto the outer surface (124) of the wing (120).

In some embodiments, an alignment bar (118) (e.g., a linear marking,groove, indentation, protrusion, etc.) is disposed in the top surface(115) of the alignment plate (110). In some embodiments, the alignmentbar (118) extends from at or near the first end (111) to at or near thesecond end (112). In some embodiments, the alignment bar (118) extendsthrough only a portion of the top surface (115) of the alignment plate(110). In some embodiments, the alignment bar (118) is a marking on oneend of the alignment plate. In some embodiments, the alignment bar (118)is a pair of markings on opposite ends of the alignment plate (110). Insome embodiments, the alignment bar (118) is intended to serve as aguide for placement of the system (100), wherein the alignment bar (118)is for aligning with the femur of the patient. In some embodiments, thealignment bar (118) is a groove or indentation. In some embodiments, thealignment bar (118) is a protrusion. In some embodiments, the alignmentbar is a marking on the alignment plate (110).

As shown in FIG. 6A, FIG. 6C, FIG. 6D, and FIG. 6E, in some embodiments,a guide wire grip (160) is disposed on the slide bar (140) (e.g., via aguide wire grip base (166). The guide wire grip (160) functions tosecure a guide wire (102) in a particular position and orientation. Insome embodiments, the guide wire grip (160) comprises one or more guidewire grip holes (168) adapted to accept a guide wire (102) (and in someembodiments temporarily hold and secure a guide wire (102)). The guidewire grip (160) may be pivotally or rotatably attached to the slide bar(140) via a guide wire grip base (166). For example, in someembodiments, the guide wire grip (160) can pivot in a first directionand second direction with respect to the guide wire grip base (166)attached to the slide bar (140). In some embodiments, the guide wiregrip base (166) is slidably attached to the slide bar (140). In someembodiments, the guide wire grip base (166) slidably engages one or moreslots (150) on the slide bar (140). In some embodiments, a guide wiregrip base channel (169) is disposed in the guide wire grip base (166),wherein the guide wire grip base channel (169) is adapted to accept theslide bar (140).

In some embodiments, the movement of the slide bar (140) along thechannel (130), the movement of the guide wire grip base (166) along theslide bar (140), the pivoting of the guide wire grip (160) in the guidewire grip base (166), and the position of the guide wire grip holes(168) allow for many different positions, angles, and orientations ofthe guide wire with respect to the patient and the area of interest.

In some embodiments, a securing component or the slide bar (140) itselfcan temporarily secure the slide bar (140) in a position (e.g., desiredposition) with respect to the channel (130). In some embodiments, asecuring component or the guide wire grip base (166) itself cantemporarily secure the guide wire grip base (166) in a position (e.g., adesired position) with respect to the slide bar (140). In someembodiments, a securing component of the guide wire grip (160) itselfcan temporarily secure the guide wire grip (160) in a position (e.g., adesired position) with respect to the guide wire grip base (166). Asshown in FIG. 6C and FIG. 6D, in some embodiments, the guide wire gripbase (166) comprises an internal-external rotation screw fixation track(188) and tightening screw hole (182) for helping to secure the guidewire grip base (166) and/or guide wire grip (160) in a particularposition.

FIG. 7 shows an alternative embodiment of a system (100) of the presentinvention. In some embodiments, the external guide system (100) of thepresent invention comprises an alignment plate (110) and one or morewings (120) that extend from the first side (113) (e.g., downwardly)from the first side (113) of the alignment plate (110), e.g., the wings(120) being positioned on opposite sides of the alignment plate (110).The system (100) may comprise a first wing (120 a) and a second wing(120 b) that extend downwardly (or downwardly and outwardly) from thefirst side (113) of the alignment plate (110). In some embodiments, thewings (120) resemble shafts or cylinders, however the wings are notlimited to a shaft or cylindrical configuration. In some embodiments,the wings (120) extend through wing channels in the alignment plate(110), e.g., the first wing (120 a) extends through a first wing channel(120 c) in the alignment plate (110), the second wing (120 b) extendsthrough a second wing channel (120 d) in the alignment plate (110). Insome embodiments, the wings (120) are perpendicular to the alignmentplate (110). In some embodiments the wings (120) are at an angle withrespect to the alignment plate (110), the angle being less than 90degrees. In some embodiments, the wings (120) are at an angle withrespect to the alignment plate (110), the angle being more than 90degrees.

Slidably disposed on each wing (120) is a positioning pin grip (170)adapted to secure a positioning pin (105) in a particular location andorientation. In some embodiments, the positioning pin grip (170) isconnected (slidably) to the wing (120) via a positioning pin grip base(176). The positioning pin grip base (176) (or the positioning pin grip(170) itself) may slide in a first direction and a second direction(e.g., upwardly, downwardly) along the wing (120) and may be secured ina particular position via a securing component. In some embodiments, thepositioning pin grip base (176) functions as a clamp around the wing(120) (e.g., tightening the positioning pin grip base (176) may securethe positioning pin grip base (176) in place with respect to the wing(120)); however the positioning pin grip base (176) is not limited tothis configuration. The positioning pin grip (170) comprises apositioning pin grip slot (172) adapted to accept a positioning pin(105). The positioning pin (105) may be secured within the positioningpin grip slot (172) via a securing component. In some embodiments, thepositioning pin grip (170) (with slot (172)) functions as a clamp aroundthe positioning pin (105) (e.g., tightening the positioning pin grip(170) may secure the positioning pin (105) in place with respect to thepositioning pin grip slot (172)); however the positioning pin grip (170)is not limited to this configuration.

In some embodiments, the system (100) further comprises a slide bar(140) adapted to engage with and slide in a channel (130) disposed inthe top surface (115) of the alignment plate (110). (In someembodiments, a channel (130) may extend from at or near the first end(111) to at or near the second end (112) of the alignment plate (110).In some embodiments, the channel (130) extends through only a portion ofthe top surface (115) of the alignment plate (110).) In someembodiments, the slide bar (140) comprises a connector (148), whichslidably engages the channel (130). In some embodiments, the slide bar(140) can slide in at least a first direction toward the first end (111)of the alignment plate (110) and/or the first wing (120 a) and a seconddirection toward the second end (112) of the alignment plate (110)and/or the second wing (120 b). In some embodiments, the wings (120)limit the distance the sliding bar (140) can slide. In some embodiments,the slide bar (140) further comprises a locking component for securingthe slide bar (140) in place within the channel (130). In someembodiments, the locking component is integrated into the connector(148) or is the connector (148) itself, e.g., the connector (148)functions as a locking component to temporarily secure the slide bar(140) in a particular place.

In some embodiments, a guide wire grip (160) is disposed on the slidebar (140) (e.g., via a guide wire grip base (166)). The guide wire grip(160) functions to secure a guide wire (102) in a particular positionand orientation. In some embodiments, the guide wire grip (160)comprises one or more guide wire grip holes (168) adapted to accept aguide wire (102) (and in some embodiments temporarily hold and secure aguide wire (102)). The guide wire grip (160) may be pivotally orrotatably attached to the slide bar (140) via a guide wire grip base(166). For example, in some embodiments, the guide wire grip (160) canpivot in a first direction and second direction with respect to theguide wire grip base (166) attached to the slide bar (140). In someembodiments, the guide wire grip base (166) is slidably attached to theslide bar (140). In some embodiments, the guide wire grip base (166)slidably engages one or more slots (150) on the slide bar (140).

In some embodiments, the movement of the slide bar (140) along thechannel (130), the movement of the guide wire grip base (166) along theslide bar (140), the pivoting of the guide wire grip (160) in the guidewire grip base (166), and the position of the guide wire grip holes(168) allow for many different positions, angles, and orientations ofthe guide wire with respect to the patient and the area of interest.

In some embodiments, a securing component or the slide bar (140) itselfcan temporarily secure the slide bar (140) in a position (e.g., desiredposition) with respect to the channel (130). In some embodiments, asecuring component or the guide wire grip base (166) itself cantemporarily secure the guide wire grip base (166) in a position (e.g., adesired position) with respect to the slide bar (140). In someembodiments, a securing component of the guide wire grip (160) itselfcan temporarily secure the guide wire grip (160) in a position (e.g., adesired position) with respect to the guide wire grip base (166). Asshown in FIG. 6C and FIG. 6D, in some embodiments, the guide wire gripbase (166) comprises an internal-external rotation screw fixation track(188) and tightening screw hole (182) for helping to secure the guidewire grip base (166) and/or guide wire grip (160) in a particularposition.

The system (100) of the present invention may be constructed from avariety of materials. In some embodiments, all or a portion of thesystem (100) is constructed from a material that is generallyradio-opaque. In some embodiments, all or a portion of the system (100)is constructed from a material that comprises acrylonitrile butadienestyrene (ABS); however, the present invention is not limited to amaterial comprising ABS.

The present invention also features methods (e.g., percutaneous methods)of positioning a guide wire in a bone at a desired position andorientation. The various degrees of freedom may be fixed independently.The present invention also features methods (e.g., percutaneous methods)of facilitating the treatment of a fracture (e.g., an IT fracture). Insome embodiments, for example in an application related to facilitatingtreatment of a fracture such as an IT fracture, the method comprisesutilizing an external angle guide system (100) of the present invention.For example, the external angle guide system (100) of the presentinvention may be placed atop a patient's leg, e.g., over the quadricepsarea. In some embodiments, the alignment bar (118) may be aligned withthe patient's femur. Placement pins (105) may be positioned and securedvia positioning pin grip slots (172) in grips (170) along the wings(120). In some embodiments, the slide bar (140) is moved within thechannel (130) of the alignment plate (110) to an appropriate position.In some embodiments, the slide bar (140) is secured with respect to thechannel (130), e.g., via the connector (148) or via a locking component(144). As previously discussed, the present invention is not limited touse with respect to IT fractures. As such, the guide system (100) of thepresent invention may be placed on any appropriate treatment area of apatient that provides access to a particular bone for guide wireplacement.

A guide wire (102) may be fed through the guide wire grip slot (162) (orslot (150)) as appropriate. For example, in some embodiments, the guidewire (102) is positioned at a particular position within the guide wiregrip slot (162) at a particular angle via the guide wire grip (160), andat a particular height via the guide wire grip base (166) along theslide bar (140). In some embodiments, the guide wire (102) is secured inthe guide wire grip slot (162) (or slot (150)) via various lockingcomponents or securing components. The present invention is not limitedto the aforementioned steps.

As previously discussed, the present invention features a percutaneousdevice and methods for placing a guide wire into a bone, e.g., placing aguide wire into the femoral head, wherein each degree of freedom isadapted to be controlled independently. As previously discussed, thereare six degrees of freedom that may be required to fully specify theposition and orientation of a body in 3D space, e.g., flexion/extensionangle, varus/valgus angulation, internal/external rotation angle,superior/inferior position, anterior/posterior position, andmedial/lateral position. As previously discussed, each degree of freedommay be controlled independently. As a non-limiting example, for examplein the case of facilitating the treatment of an IT fracture, in someembodiments, the method comprises placing the device on a patient'sthigh, aligning the v/v angulation, fixing the percutaneous device tothe femur, selecting i/e rotation, fixing i/e rotation, selecting a/pposition, and fixing the a/p position. X-ray images may be used (at oneor more times during the process) to help verify placement of the guideposition. In some embodiments, once the varus/valgus plane is fixed, thesuperior/inferior position may be addressed. In some embodiments, theability to slide the guide wire (102) up and down with respect to theslide plate (140) may help to set the superior/inferior position. Insome embodiments, x-ray images may be taken to observe that the guidewire (102) is at the correct superior/inferior position in theintertrochanteric fracture.

The system (100) of the present invention allows for a single parameter(e.g., v/v angulations) to be set prior the setting of a secondparameter (e.g., s/I position), and adjustment of the second parametermay not necessitate the adjustment of the first parameter after it isset.

As used herein, the term “about” refers to plus or minus 10% of thereferenced number.

The disclosures of the following patents/patent applications areincorporated in their entirety by reference herein: U.S. Pat. Nos.6,562,042; 7,927,333; CN02215612; CN201310308203; CN201310072356;CN201320103500.

Various modifications of the invention, in addition to those describedherein, will be apparent to those skilled in the art from the foregoingdescription. Such modifications are also intended to fall within thescope of the appended claims. Each reference cited in the presentapplication is incorporated herein by reference in its entirety.

Although there has been shown and described the preferred embodiment ofthe present invention, it will be readily apparent to those skilled inthe art that modifications may be made thereto which do not exceed thescope of the appended claims. Therefore, the scope of the invention isonly to be limited by the following claims. Reference numbers recited inthe claims are exemplary and for ease of review by the patent officeonly, and are not limiting in any way. In some embodiments, the figurespresented in this patent application are drawn to scale, including theangles, ratios of dimensions, etc. In some embodiments, the figures arerepresentative only and the claims are not limited by the dimensions ofthe figures. In some embodiments, descriptions of the inventionsdescribed herein using the phrase “comprising” includes embodiments thatcould be described as “consisting of”, and as such the writtendescription requirement for claiming one or more embodiments of thepresent invention using the phrase “consisting of” is met.

The reference numbers recited in the below claims are solely for ease ofexamination of this patent application, and are exemplary, and are notintended in any way to limit the scope of the claims to the particularfeatures having the corresponding reference numbers in the drawings.

What is claimed is:
 1. An external guide system (100) for placing aguide wire (102) into a bone at a particular position and orientation,said system (100) comprising: a. an alignment plate (110) for placementatop a leg, the alignment plate (110) is defined by a top surface (115)and a bottom surface, a first side (113) and a second side (114)opposite the first side (113), and a first end (111) and a second end(112) opposite the first end (111); b. a first wing (120 a) extendingfrom an intersection of the first side (113) and the bottom surface ofthe alignment plate at or near the first end (111) downwardly in aperpendicular direction away from the bottom surface of the alignmentplate (110) and a second wing (120 b) extending from an intersection ofthe first side (113) and the bottom surface of the alignment plate (110)at or near the second end (112) downwardly in a perpendicular directionaway from the bottom surface of the alignment plate (110); c. apositioning pin grip (170) slidably attached to the first wing (120 a)and a positioning pin grip (170) slidably attached to the second wing(120 b), the positioning pin grip (170) slidably attached to the firstwing (120 a) and the positioning pin grip (170) slidably attached to thesecond wing (120 b) can be slid in a first direction toward thealignment plate (110) and a second direction opposite the firstdirection, wherein the positioning pin grip (170) slidably attached tothe first wing (120 a) and the positioning pin grip (170) slidablyattached to the second wing (120 b) each comprise a positioning pin gripslot (172) adapted to accept a placement pin (105); d. a slide bar (140)slidably engaged in a channel (130) disposed in the top surface (115) ofthe alignment plate (110) extending from near the first end (111) to thesecond end (112), the slide bar (140) extends downwardly from the firstside (113) of the alignment plate (110) in a direction away from thebottom surface of the alignment plate (110) such that the slide bar(140) is both parallel to and in between the first wing (120 a) and thesecond wing (120 b) and when viewed from the first end (111) or thesecond end (112) of the alignment plate (110), the slide bar (140) isparallel to and aligned with the first wing (120 a) and the second wing(120 b), the slide bar (140) can slide in at least a first directiontoward the first end (111) of the alignment plate (110) and a seconddirection toward the second end (112) of the alignment plate (110); e. aguide wire grip (160) with a guide wire grip slot (162) disposed thereinadapted to position and hold a guide wire (102), the guide wire grip(160) is pivotally attached to a guide wire grip base (166) wherein theguide wire grip (160) can pivot within the guide wire grip base (166) ina first direction toward the alignment plate (110) and a seconddirection opposite the first direction, wherein the guide wire grip base(166) is slidably attached to a guide wire grip shaft (164) disposed onthe slide bar (140) such that it can slide in a first direction towardthe alignment plate and a second direction opposite the first direction;wherein the system (100) is adapted to allow independent positioning offlexion-extension angle, varus-valgus angulation, internal-externalrotation angle, superior-inferior position, anterior-posterior position,and medial-lateral position of the guide wire (102).
 2. An externalguide system (100) for placing a guide wire (102) into a bone at aparticular position and orientation, said system (100) comprising: a. analignment plate (110) for placement atop a leg, the alignment plate(110) is defined by a top surface (115) and a bottom surface, a firstside (113) and a second side (114) opposite the first side (113), and afirst end (111) and a second end (112) opposite the first end (111); b.a first wing (120 a) extending from an intersection of the first side(113) and the bottom surface of the alignment plate (110) at or near thefirst end (111) downwardly in a perpendicular direction away from thebottom surface of the alignment plate (110), and a second wing (120 b)extending from an intersection of the first side (113) and the bottomsurface of the alignment plate at or near the second end (112) of thealignment plate downwardly in a perpendicular direction away from thebottom surface of the alignment plate (110), the first wing (120 a) andsecond wing (120 b) are for directly or indirectly positioning andholding a placement pin (105); c. a slide bar (140) slidably engaged ina channel (130) disposed in the top surface (115) of the alignment plate(110) extending from near the first end (111) to the second end (112),the slide bar (140) extends downwardly from the first side (113) of thealignment plate (110) in a direction away from the bottom surface of thealignment plate (110) such that the slide bar (140) is both parallel toand in between the first wing (120 a) and the second wing (120 b) andwhen viewed from the first end (111) or the second end (112) of thealignment plate (110), the slide bar (140) is parallel to and alignedwith the first wing (120 a) and the second wing (120 b), the slide bar(140) can slide in at least a first direction toward the first end (111)of the alignment plate (110) and a second direction toward the secondend (112) of the alignment plate (110); d. a guide wire grip (160)adapted to position and hold a guide wire (102), the guide wire grip(160) is pivotally attached to a guide wire grip base (166) wherein theguide wire grip (160) can pivot within the guide wire grip base (166) ina first direction toward the alignment plate (110) and a seconddirection opposite the first direction, wherein the guide wire grip base(166) is slidably attached to the slide bar (140) such that it can slidein a first direction toward the alignment plate and a second directionopposite the first direction; wherein the system (100) is adapted toallow independent positioning of flexion-extension angle, varus-valgusangulation, internal-external rotation angle, superior-inferiorposition, anterior-posterior position, and medial-lateral position ofthe guide wire (102).
 3. The system (100) of claim 2 comprising apositioning pin grip (170) slidably attached to the first wing (120 a)and a positioning pin grip (170) slidably attached to the second wing(120 b), the positioning pin grip (170) slidably attached to the firstwing (120 a) or the positioning pin grip (170) slidably attached to thesecond wing (120 b) can be slid in a first direction toward thealignment plate (110) and a second direction opposite the firstdirection.
 4. The system (100) of claim 3, wherein the positioning pingrip (170) comprises a positioning pin grip slot (172) adapted to accepta positioning pin (105).
 5. The system (100) of claim 2, wherein thefirst wing (120 a) and the second wing (120 b) both comprise a pluralityof holes (128) disposed therethrough that allow passage of a placementpin (105), the holes are at a first hole angle (129 a) with respect to alength of the first wing (120 a) or second wing (120 b), respectively,and at a second hole angle (129 b) with respect to a width of the firstwing (120 a) or second wing (120 b), respectively, the first hole angle(129 a) is from 20 to 90 degrees and the second hole angle (129 b) isfrom 20 to 90 degrees.
 6. The system (100) of claim 2, wherein the slidebar (140) slidably engages the channel (130) via a connector (148). 7.The system (100) of claim 2, wherein the slide bar (140) comprises aguide wire grip shaft (164), wherein the guide wire grip base (166) isslidably attached to the guide wire grip shaft (164) and can slide inthe first direction and second direction along the slide bar (140) viathe guide wire grip shaft (164).
 8. The system (100) of claim 2, whereinthe guide wire grip base (166) engages a slot (150) is disposed in theslide bar (140), the slot (150) extends along at least a part of alength of the slide bar (140).
 9. The system (100) of claim 2, whereinthe guide wire grip (160) comprises a guide wire grip slot (162) adaptedto accept a guide wire (102), wherein a guide wire (102) can slidewithin the guide wire grip slot (162) in a first direction and seconddirection opposite the first direction.
 10. The system (100) of claim 2,wherein the guide wire grip (160) comprises one more guide wire gripholes (168) adapted to accept a guide wire (102).
 11. The system (100)of claim 2, wherein the system (100) is for placing a guide wire (102)into a bone for facilitating treatment of a fracture or an osteotomy.